Japan Flavour and Fragrance Materials Association’s (JFFMA) safety assessment of food-flavouring substances uniquely used in Japan that belong to the class of aliphatic primary alcohols, aldehydes, carboxylic acids, acetals and esters containing additional oxygenated functional groups

ABSTRACT

We performed a safety evaluation using the procedure devised by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) of the following four flavouring substances that belong to the class of ‘aliphatic primary alcohols, aldehydes, carboxylic acids, acetals, and esters containing additional oxygenated functional groups’ and are uniquely used in Japan: butyl butyrylacetate, ethyl 2-hydroxy-4-methylpentanoate, 3-hydroxyhexanoic acid and methyl hydroxyacetate. Although no genotoxicity study data were found in the published literature, none of the four substances had chemical structural alerts predicting genotoxicity. All four substances were categorised as class I by using Cramer’s classification. The estimated daily intake of each of the four substances was determined to be 0.007–2.9 μg/person/day by using the maximised survey-derived intake method and based on the annual production data in Japan in 2001, 2005 and 2010, and was determined to be 0.250–600.0 μg/person/day by using the single-portion exposure technique and based on average-use levels in standard portion sizes of flavoured foods. Both of these estimated daily intake ranges were below the threshold of toxicological concern for class I substances, which is 1800 μg/person/day. Although no information from in vitro and in vivo toxicity studies for the four substances was available, these substances were judged to raise no safety concerns at the current levels of intake.

Graphical Abstract

KEYWORDS:

• Aliphatic primary alcohols
• aldehydes
• carboxylic acids
• acetals
• and esters containing additional oxygenated functional groups
• Cramer decision tree
• food flavours
• Joint FAO/WHO Expert Committee on Food Additives (JECFA)
• safety
• threshold of toxicological concern

Acknowledgments

The authors thank Professor Takeshi Yamazaki, Department of Food and Health Sciences, Jissen Women’s University, for his expert advice in preparing the manuscript.

Disclosure statement

Kenji Saito, Fumiko Sekiya, Shim-mo Hayashi, Yoshiharu Mirokuji, Hiroyuki Okamura and Shinpei Maruyama are employed by flavour manufacturers whose product lines include flavouring substances. The views and opinions expressed in this article are those of the authors and not necessarily those of their respective employers. Yasuko Hasegawa-Baba, Atsushi Ono, Madoka Nakajima, Masakuni Degawa, Shogo Ozawa, Makoto Shibutani and Tamio Maitani declare that no conflicts of interest exist.

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Funding

This work was supported by the Japan Flavour and Fragrance Materials Association.